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Completed

NCT Number: NCT00132912

Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.

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Key information

Conditions

Arterial Obstructive Diseases Arterial Occlusive Diseases Cardiovascular Diseases Coronary Disease Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
  • A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
  • If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion criteria

  • Pregnancy
  • Recent stroke
  • Active internal bleeding or a history of a bleeding disorder
  • Increased risk of bleeding
  • Severe high blood pressure
  • Liver or kidney disease
  • Low platelet count
  • Condition such as alcoholism, mental illness, or drug dependence
  • Ongoing chest pain
  • Planned or ongoing treatment with a blood thinning medication
  • A serious condition or illness that would interfere with participation in the study

Treatment and study plan

SCH 530348

Drug

Primary outcomes

  1. Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

Secondary outcomes

  1. Incidence of bleeding throughout treatment and follow-up

  2. Incidence of death and major adverse cardiac events

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2005
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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